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6 results on '"Leonard B. Seeff"'

1. United States Pharmacopeia (USP) comprehensive review of the hepatotoxicity of green tea extracts

Author

Hellen A. Oketch-Rabah, Amy L. Roe, Cynthia V. Rider, Herbert L. Bonkovsky, Gabriel I. Giancaspro, Victor Navarro, Mary F. Paine, Joseph M. Betz, Robin J. Marles, Steven Casper, Bill Gurley, Scott A. Jordan, Kan He, Mahendra P. Kapoor, Theertham P. Rao, Averell H. Sherker, Robert J. Fontana, Simona Rossi, Raj Vuppalanchi, Leonard B. Seeff, Andrew Stolz, Jawad Ahmad, Christopher Koh, Jose Serrano, Tieraona Low Dog, and Richard Ko

Subjects
Green tea, Camellia sinensis, Dietary supplements, Hepatotoxicity, Liver injury, Green tea extract, Toxicology. Poisons, RA1190-1270
Abstract

As part of the United States Pharmacopeia’s ongoing review of dietary supplement safety data, a new comprehensive systematic review on green tea extracts (GTE) has been completed. GTEs may contain hepatotoxic solvent residues, pesticide residues, pyrrolizidine alkaloids and elemental impurities, but no evidence of their involvement in GTE-induced liver injury was found during this review. GTE catechin profiles vary significantly with manufacturing processes. Animal and human data indicate that repeated oral administration of bolus doses of GTE during fasting significantly increases bioavailability of catechins, specifically EGCG, possibly involving saturation of first-pass elimination mechanisms. Toxicological studies show a hepatocellular pattern of liver injury. Published adverse event case reports associate hepatotoxicity with EGCG intake amounts from 140 mg to ∼1000 mg/day and substantial inter-individual variability in susceptibility, possibly due to genetic factors. Based on these findings, USP included a cautionary labeling requirement in its Powdered Decaffeinated Green Tea Extract monograph that reads as follows: “Do not take on an empty stomach. Take with food. Do not use if you have a liver problem and discontinue use and consult a healthcare practitioner if you develop symptoms of liver trouble, such as abdominal pain, dark urine, or jaundice (yellowing of the skin or eyes).”

Published
2020
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2. United States Pharmacopeia (USP) comprehensive review of the hepatotoxicity of green tea extracts

Author

Raj Vuppalanchi, Mary F. Paine, Robin J. Marles, Steven J. Casper, Leonard B. Seeff, Bill J. Gurley, Hellen A. Oketch-Rabah, Tieraona Low Dog, Amy L. Roe, Jawad Ahmad, Scott A. Jordan, Gabriel I. Giancaspro, Andrew Stolz, Cynthia V. Rider, Christopher Koh, Richard Ko, Averell H. Sherker, Kan He, Jose Serrano, Robert J. Fontana, Herbert L. Bonkovsky, Víctor M. Navarro, Joseph M. Betz, Theertham P. Rao, Simona Rossi, and Mahendra P. Kapoor

Subjects
NAA, N-acetyl aspartate, EGCG, (–)‐epigallocatechin‐3‐gallate, CIH, Concanavalin A-induced hepatitis, Health, Toxicology and Mutagenesis, AST, aspartate aminotransferase, Green tea extract, 010501 environmental sciences, Liver injury, Toxicology, 01 natural sciences, Camellia sinensis, AUC, area under the curve, chemistry.chemical_compound, NIH, National Institutes of Health, 0302 clinical medicine, Bolus (medicine), Oral administration, TGF-beta, Transforming growth factor beta, DSAE, JS3 USP Dietary Supplements Admission Evaluations Joint Standard-Setting Subcommittee, LFT(s), liver function test(s), PK/PD, pharmacokinetics and pharmacodynamics, C, Catechin, 2. Zero hunger, PAs, Pyrrolizidine Alkaloids, Traditional medicine, Regular Article, Catechin, Jaundice, Dietary supplements, ConA, Concanavalin A, 3. Good health, COMT, catechol‐O‐methyltransferase, GT, green tea, CMC, chemistry, manufacturing, and controls, GCG, (–)‐gallocatechin‐3‐gallate, HPMC, Hydroxypropyl methylcellulose, LD50, lethal dose, median, NIDDK, National Institute of Diabetes and Digestive and Kidney Diseases, medicine.symptom, HDS, herbal dietary supplement, PDGTE, powdered decaffeinated green tea extract, Bw, body weight, DO, Diversity Outbred, FDA, United States Food and Drug Administration, EC, (–)‐epicatechin, ECG, (‐)‐epicatechin‐3‐gallate, CG, (+)‐catechin‐3‐gallate, MGTT, Minnesota Green Tea Trial, NOAEL, no observed adverse effect level, DILI, drug‐induced liver injury, EFSA, European Food Safety Authority, ADME, Absorption, distribution, metabolism, and excretion, γ-GT, Gamma-glutamyl transferase, GTEH, EP Green Tea Extract Hepatotoxicity Expert Panel, USP, United States Pharmacopeia, MRL, maximum residue limit, NTP, National Toxicology Program, 03 medical and health sciences, SIDS, single-ingredient dietary supplement, lcsh:RA1190-1270, ALT, alanine aminotransferase, OSM, online supplementary material, medicine, PD-1, Programmed death domain-1, Adverse effect, RUCAM, Roussel Uclaf Causality Assessment Method, 0105 earth and related environmental sciences, lcsh:Toxicology. Poisons, LT(s), Liver test(s), ALP, alkaline phosphatase, business.industry, Hepatotoxicity, GT(E), green tea or green tea extract, Green tea, medicine.disease, Bioavailability, CAM, causality assessment method, GTE, green tea extract, MIDS, multi-ingredient dietary supplement, chemistry, EGC, (–)‐epigallocatechin, DS, Dietary Supplement, GC, (+)‐gallocatechin, DILIN, Drug‐Induced Liver Injury Network, business, 030217 neurology & neurosurgery
Abstract

As part of the United States Pharmacopeia’s ongoing review of dietary supplement safety data, a new comprehensive systematic review on green tea extracts (GTE) has been completed. GTEs may contain hepatotoxic solvent residues, pesticide residues, pyrrolizidine alkaloids and elemental impurities, but no evidence of their involvement in GTE-induced liver injury was found during this review. GTE catechin profiles vary significantly with manufacturing processes. Animal and human data indicate that repeated oral administration of bolus doses of GTE during fasting significantly increases bioavailability of catechins, specifically EGCG, possibly involving saturation of first-pass elimination mechanisms. Toxicological studies show a hepatocellular pattern of liver injury. Published adverse event case reports associate hepatotoxicity with EGCG intake amounts from 140 mg to ∼1000 mg/day and substantial inter-individual variability in susceptibility, possibly due to genetic factors. Based on these findings, USP included a cautionary labeling requirement in its Powdered Decaffeinated Green Tea Extract monograph that reads as follows: “Do not take on an empty stomach. Take with food. Do not use if you have a liver problem and discontinue use and consult a healthcare practitioner if you develop symptoms of liver trouble, such as abdominal pain, dark urine, or jaundice (yellowing of the skin or eyes).”

Published
2020

3. Hepatotoxicity of Herbal Preparations

Author

Leonard B. Seeff, Victor J. Navarro, and Doris B. Strader

Subjects
Traditional medicine, business.industry, Herbal preparations, Medicine, business
Published
2012

4. Contributors

Author

Paul C. Adams, Helmut Albrecht, Jasmohan Bajaj, Soon Koo Baik, Ulrich Beuers, Scott W. Biggins, Henri Bismuth, Kirsten Muri Boberg, Herbert L. Bonkovsky, Jaime Bosch, Thomas D. Boyer, Elizabeth M. Brunt, Martin Caselitz, Wolfgang H. Caselmann, Matt Cave, Henry Lik-Yuen Chan, Kyong-Mi Chang, Alessia Ciancio, Massimo Colombo, Hari S. Conjeevaram, Diane W. Cox, Chris P. Day, R. Brian Doctor, Ronald P.J. Oude Elferink, Scott A. Elisofon, Hashem B. El-Serag, Gamal Esmat, Gregory T. Everson, Keith Cameron Falkner, Michael B. Fallon, Sandy Feng, Hans-Peter Fischer, Brett E. Fortune, Scott L. Friedman, J.C. García-Pagán, Guadalupe Garcia-Tsao, Fayez K. Ghishan, Gregory J. Gores, Rainer W. Gruessner, Sanjeev Gupta, Ghassan M. Hammoud, E.J. Heathcote, Steve M. Helmke, G.M. Hirschfield, Douglas Hunt, Massimo Iavarone, Jamal A. Ibdah, Françoise Imbert-Bismut, Peter L.M. Jansen, Benjamin F. Johnson, Maureen M. F. Jonas, Dean P. Jones, Patrick S. Kamath, Tom H. Karlsen, Deirdre Kelly, J. Kettelle, Khalid M. Khan, Percy Knolle, David J. Kramer, Manoj Kumar, Navaneeth C. Kumar, Jennifer C. Lai, Réal Lapointe, Konstantinos N. Lazaridis, André Lechel, Samuel S. Lee, Riccardo Lencioni, Cynthia Levy, Keith D. Lindor, Stephen Locarnini, Anna S.F. Lok, Harmeet Malhi, Michael P. Manns, Jorge A. Marrero, Craig McClain, Robert McCuskey, Barbara H. McGovern, John G. McHutchison, Darius Moradpour, Victor J. Navarro, James Neuberger, Moises I. Nevah R., Yulia A. Nevzorova, Heather M. Patton, François Penin, David Perlmutter, Aurélie Plessier, Thierry Poynard, Puneet Puri, Charles Rice, Mario Rizzetto, Eve A. Roberts, Don C. Rockey, Jayanta Roy-Chowdhury, Namita Roy-Chowdhury, K. Lenhard Rudolph, Mark W. Russo, Sammy Saab, Arun J. Sanyal, S.K. Sarin, Erik Schrumpf, Leonard B. Seeff, S. Seijo, Vijay H. Shah, Steven I. Shedlofsky, Daniel Shouval, Claude B. Sirlin, Maxwell L. Smith, Emmanuil Smorodinsky, Ulrich Spengler, Richard K. Sterling, Stephen F. Stewart, Doris B. Strader, Christian P. Strassburg, R. Todd Stravitz, Priti Sud, Mark S. Sulkowski, Jayant A. Talwalkar, Norah A. Terrault, Hans L. Tillmann, Christian Trautwein, Parsia A. Vagefi, Dominique Valla, Siegfried Wagner, Nadia Warner, Vincent Wai-Sun Wong, and Naglaa Zayed

Published
2012

6. 5 Natural history of hepatitis C

Author

Leonard B. Seeff

Subjects
Natural history, business.industry, medicine, Hepatitis C, medicine.disease, business, Virology
Published
2000

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